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Registration

The registration of medicinal products is ensured by the Italian Medicines Agency through the procedures provided by the European set of laws:

national procedure

community procedure

Through these procedures and supported by adequate software applications that ensure traceability, transparency and timeliness throughout the registration process, the Agency guarantees:

homogeneity of the pharmaceutical assistance over the national territory

access to innovative medicinal products and to drugs for rare diseases

The national procedure allows the marketing authorization of a medicinal product only in Italy, though assessment and registration process complies with the same criteria foreseen by the EU procedures, since the national legislation integrally implements the EU Directives.

The community procedures of marketing authorization of new medicinal products are divided into:

Mutual Recognition Procedure, allowing the extension of a marketing authorization granted by a Member State to one or more other Countries of the European Union;

Decentralized Procedure, allowing to obtain a single marketing authorization simultaneously valid in most countries of the European Union for a medicinal product which has been not yet authorized in Europe.

Activities

AIFA, through the Assessment and Registration Unit, is responsible for the activities related to administrative and technical-scientific assessment of documentation submitted for:

new Marketing Authorization requests

variations to the terms of medicinal products already authorized.

In this context the Agency follows all the stages of the process, from the submission of the request to the final release of the marketing authorization (AIC), in accordance with the national procedures and with the Community ones in which Italy is the Reference or Concerned Member State (FORM_AIFA.RMS) - (Mod.309/2).

Such activities are performed for all categories of medicinal products for human use, included biologicals, human blood products, radiopharmaceuticals, medicinal gasses, herbals and homeopathic medicinal products.

Within the activities concerning the parallel import/export of medicinal products licensed according to the Mutual Recognition Procedure, AIFA provides the requesting Regulatory Authorities of the other Member States with information regarding some of the identification elements of the medicinal products authorized in Italy.

Aifa is also responsible for the application of the provisions related to the “sunset clause” for all medicinal products authorized in Italy.

Assessment

Within the assessment process, the Agency deals with the administrative and technical-scientific assessment of the dossier submitted for marketing authorization or variations to the terms of medicinal products for human use under national or Community procedure. The assessment aims at ensuring adequate standards of quality, safety and efficacy of all the medicinal products, through chemical, pharmaceutical, biological, pharma-toxicological and clinical assessments.

Such assessment is fulfilled with the assistance of the Technical Scientific Commission (CTS), with the co-operation of experts belonging to the National Institute of Health (ISS) and of other experts of well-known experience belonging to the Italian academic and health community. Moreover, the assessment activities are carried out in close collaboration with the other European countries involved in the assessment process and in accordance with the guidelines issued by the European Medicines Agency and the International Conference on Harmonisation - ICH, that in turns are periodically revised according to the latest ongoing updates in the scientific community. For this purpose AIFA is represented in all the relevant European seats.

Registration

The Agency takes care of finalizing the outcome of the positive assessment of medicinal products issuing the relative marketing authorization (AIC). Therefore, the UVA verifies the completeness and the propriety of the administrative dossier submitted for the requests and makes a linguistic review of the Summary Of Product Characteristics, the patient information leaflet and the label of the medicinal products authorized under the Community procedure.

In order to ensure transparency in the authorization process a computerized system of transparency is available for the pharmaceutical companies, who can obtain online information about the progress of their requests of authorization and variations to the terms of authorization submitted to the AIFA, with regard to national, mutual recognition and decentralized procedures.

The system provides weekly updated information and is completed with a box-office instrument, through which the companies can forward to Aifa the queries about procedures recorded on the transparency system and receive prompt response from the offices in 48 hours. Such instrument of communication is supported by the function of patterned data storage and research of messages, in order to facilitate the organization and the tracking record of the correspondence.